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Stabilization Period (stabilization + period)
Selected AbstractsEfficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapyDIABETES OBESITY & METABOLISM, Issue 2 2009R. E. Pratley Aim:, To evaluate the efficacy and safety of alogliptin, a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, in combination with glyburide in patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy. Methods:, After a 2-week screening period, adult patients 18,80 years of age entered a 4-week run-in/stabilization period in which they were switched from their own sulphonylurea medication to an equivalent dose of glyburide (open label) plus placebo (single blind). After the run-in period, patients were randomly assigned to double-blind treatment with alogliptin 12.5 mg (n = 203), alogliptin 25 mg (n = 198), or placebo (n = 99) for 26 weeks. The primary end-point was change from baseline to week 26 in glycosylated haemoglobin (HbA1c). Secondary end-points included clinical response rates and changes in fasting plasma glucose, ,-cell function (fasting proinsulin, insulin, proinsulin/insulin ratio, and C-peptide, and homeostasis model assessment ,-cell function), body weight, and safety end-points [adverse events (AEs), clinical laboratory tests, vital signs and electrocardiographic readings]. Results:, The study population had a mean age of 57 years and a mean disease duration of 8 years; it was well balanced for gender (52% women) and was mainly white (71%). The mean baseline HbA1c was approximately 8.1% in each group. Significantly greater least squares (LS) mean reductions in HbA1c were seen at week 26 with alogliptin 12.5 mg (,0.38%) and 25 mg (,0.52%) vs. placebo (+0.01%; p < 0.001), and more patients in the alogliptin 25-mg group had HbA1c levels ,7.0% at week 26 (34.8%, p = 0.002) vs. placebo (18.2%). Proportionately more patients in the alogliptin 12.5 mg (47.3%) and 25 mg (50.5%) groups had an HbA1c reduction ,0.5% from baseline compared with patients in the placebo group (26.3%; p < 0.001). Minor improvements in individual markers of ,-cell function were seen with alogliptin, but no significant treatment group differences were noted relative to placebo. Minor LS mean changes in body weight were noted across groups (placebo, ,0.20 kg; alogliptin 12.5 mg, +0.60 kg; alogliptin 25 mg, +0.68 kg). AEs were reported for 63,64% of patients receiving alogliptin and 54% of patients receiving placebo. Few AEs were treatment limiting (2.0,2.5% across groups), and serious AEs (2.0,5.6%) were infrequent, similar across groups, and generally considered not related to treatment. The incidences of hypoglycaemia for placebo, alogliptin 12.5 mg and alogliptin 25 mg groups were 11.1, 15.8 and 9.6% respectively. Conclusions:, In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia. [source] Effects of oat processing on the glycaemic and insulin responses in horsesJOURNAL OF ANIMAL PHYSIOLOGY AND NUTRITION, Issue 3-4 2003I. Vervuert Summary This study was conducted to evaluate the effects of different oat processing techniques on the plasma glucose and insulin response in horses. In a cross-over design, six horses (ages 4,15 years, mean body weight ± SD: 450 ± 37 kg) were fed in random order: untreated oats, finely ground, steam-flaked and popped oats. The total oat intake varied between 1.05,1.5 kg/day, and the amount of diet was adjusted to a starch content of 630 g starch per day and horse (1.2,1.5 g starch/kg BW/day). During the stabilization period of 10 days, horses additionally received 6 kg grass hay. Following this adaptation period, plasma glucose and insulin responses to the respective dietary treatments were tested. Horses were fed their test diet (exclusively oats), and blood samples were collected at defined times to determine glycaemic and insulin response. Oat feeding resulted in a significant increase in mean plasma glucose and insulin concentration. However, glucose and insulin peaks as well as their respective areas under the curves were not clearly influenced by oat processing. The glycaemic index varied between 94.7 ± 11.2% (steam-flaked oats) and 102.6 ± 14.5% (finely ground oats, n.s.), the insulin index ranged between 93.8 ± 18.9% (popped oats) and 150.0 ± 77.6% (finely ground oats, n.s.). The insulin reaction to oat feeding showed a high variability between the horses. The results of this study indicate that the glucose and insulin responses are not clearly altered by the different types of oat processing. However, the glucose and insulin responses tended to be lower in thermally treated oats when compared with untreated or finely ground oats. [source] Crosslinking of PVC formulations treated with UV lightJOURNAL OF VINYL & ADDITIVE TECHNOLOGY, Issue 2 2006G. Arias Typical wire and cable formulations of plasticized Poly(vinyl chloride) were prepared with three different stabilizer systems: Ca/Zn (2:1 or 1:1) and dibasic lead phthalate. The mixtures contained trimethylolpropane trimethacrylate (TMPTMA) as crosslinking agent and a UV photoinitiator (Irgacure 819). Mixtures were dry-blended, then roll-milled and to finally hot-pressed at 180°C to obtain sheets of 1 and 1.5 mm thickness. Small specimens (3 × 3 cm) were irradiated with UV light for up to 10 days while monitoring changes at different time intervals. The presence of TMPTMA in the samples, as expected, influenced the storage modulus (E,) and gel content percentage, specifically for the thinner samples. These results indicated that UV irradiation produced surface crosslinking. The samples with crosslinking agent also reached higher carbonyl index values. The Ca/Zn formulations showed higher mechanical properties with respect to the Pb ones, thus suggesting that during the stabilization period of the Ca/Zn mixtures, an effective crosslinking was promoted. Irregular behavior was observed during the last days of treatment for both types of formulations, thereby suggesting an optimum irradiation time for this procedure. J. VINYL. ADDIT. TECHNOL. 12:49,54, 2006. © 2006 Society of Plastics Engineers. [source] Cephalometric evaluation of the effects of pendulum appliance on various vertical growth patterns and of the changes during short-term stabilizationORTHODONTICS & CRANIOFACIAL RESEARCH, Issue 1 2001Ms Toro The aim of this study was to evaluate the effects of the pendulum appliance in dental Class II patients with varying vertical growth patterns and to evaluate the changes during the short-term stabilization period of 3 months. The sample (n=30) was divided into two groups based on their FMA°. The high-angle group consisted of 14 patients (10 girls and 4 boys) and had a mean age of 157.7±8.0 months. The low-angle group consisted of 16 patients (8 girls and 8 boys) and had a mean age of 155.5±18.6 months. Pretreatment, posttreatment and poststabilization cephalometric radiographs were obtained to measure the changes. Mann,Whitney U and Wilcoxon tests were used for statistical evaluation. The amount of upper molar distalization was 5.9 mm (p<0.001) in the high-angle group and 1 mm (p<0.001) in the low-angle group, showing no intergroup difference. The amount of anchorage loss at the second premolars was 4.8 mm (p<0.001) in the high-angle group and 6.6 mm (p<0.001) in the low-angle group. Upper incisors moved anteriorly for 2.1 mm (p<0.05) in the high-angle group and 4.1 mm (p<0.001) in the low-angle group. Intergroup difference was statistically significant (p<0.001). During the stabilization period, 1.5 mm of anchorage loss was measured at the upper molar region in the high-angle group and 1.7 mm of anchorage loss was measured at the upper molar region in the low-angle group. During the stabilization period, upper second premolars and incisors tended to move back to their original places. The results of this study showed that pendulum appliance could move the upper molars distally in a short period of time without depending on the patient compliance. Care should be taken to prevent anchorage loss and to stabilize the upper molars for, at least, 3 months. [source] Episodes of hypoxemia during synchronized intermittent mandatory ventilation in ventilator-dependent very low birth weight infantsPEDIATRIC PULMONOLOGY, Issue 1 2005Steve R.E. Firme MD Abstract Distinct patterns of asynchrony, and episodes of hypoxemia, may occur in a spontaneously breathing preterm infant during conventional intermittent mandatory ventilation (IMV) on traditional time-cycled, pressure-limited ventilators. Synchronized IMV (SIMV) and assist/control ventilation are frequent modes of patient-triggered ventilation used with infant ventilators. The objective of this study was to use computerized pulse oximetry to quantify the occurrence of episodes of hypoxemia (oxygen desaturation) during SIMV vs. IMV, in preterm infants ,1,250 g who required mechanical ventilation at ,14 days of age. We performed a randomized, crossover study with each infant being randomized to IMV or SIMV (Infant Star ventilator) for initial testing for a 1-hr period. Patients were subsequently tested on the alternate modality after a stabilization period of 10 min at the same ventilator and fractional inspired oxygen concentration (FiO2) settings. Pulse oximetry data were obtained with a Nellcor N-200 monitor, a microcomputer, and a software program (SatMaster). An investigator blinded to the randomized assignment evaluated all measurements. Eighteen very low birth weight (VLBW) infants with a birth weight of 777,±,39 g (mean,±,SEM) and gestational age 25.1,±,0.3 weeks were studied. The average pulse oximeter oxygen saturation (SaO2) was higher on SIMV than IMV (P,<,0.01). During SIMV, these infants had significantly fewer episodes of hypoxemia (duration of episodes of oxygen desaturation as a percentage of scorable recording time) to 86,90% SaO2 (P,<,0.01), 81,85% SaO2 (P,<,0.01), and 76,80% SaO2 (P,<,0.05) when compared to IMV. There was also a significant decrease in percentage of time of desaturation to SaO2,<,90% (P,=,0.002),,<,85% SaO2 (P,=,0.003), and <80% SaO2 (P,=,0.02) during SIMV vs. IMV. Our preliminary findings indicate that the use of SIMV in a population of VLBW ventilator-dependent infants (,14 days of age) results in better oxygenation and decreased episodes of hypoxemia as compared to IMV. © 2005 Wiley-Liss, Inc. [source] Titration with Oxymorphone Extended Release to Achieve Effective Long-Term Pain Relief and Improve Tolerability in Opioid-Naive Patients with Moderate to Severe PainPAIN MEDICINE, Issue 7 2008Richard Rauck MD ABSTRACT Objective., Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients. Design., Open-label, nonrandomized 6-month study with a titration/stabilization period of ,1 month followed by a 5-month maintenance period. Setting., Multidisciplinary pain centers in the United States. Patients., Adult opioid-naive patients with moderate to severe chronic pain. Interventions., Patients were gradually titrated from a 5-mg dose of oxymorphone ER (taken every 12 hours) to a stabilized dose that provided effective pain relief and was well tolerated. Outcome Measures., Brief Pain Inventory Short Form questions 5 and 9, patient and physician global assessments of pain relief, adverse events (AEs), and discontinuations. Results., The majority (94/126; 75%) of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable AEs. Most (81/94; 86%) required <24 days to reach a stable dose. Sixteen percent of patients in the titration period and 17% of patients in the maintenance period discontinued because of AEs possibly or probably related to oxymorphone ER. Patients completing the entire 5-month maintenance period experienced effective pain relief with significant (>50%) reductions of pain interference with quality-of-life measures. There was minimal dose escalation over the 5 months and low use of rescue medication. Conclusions., Oxymorphone ER provided effective pain relief from moderate to severe chronic pain in opioid-naive patients. Gradual titration was well tolerated, with a low rate of discontinuations caused by AEs. [source] | ||||||||||